Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR
研究概览
简要总结
With the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate. Purpose of this study is: 1) to assess the feasibility to re-engage coronary ostia after TAVR; 2) to discover potential native anatomical or prosthesis-related features that may preclude proper coronary cannulation after TAVR.
详细描述
Single-center, prospective, pilot study. Aim of this study is to assess the feasibility of coronary ostia re-engagement beyond transcatheter aortic valve (TAV) stent through a transfemoral access in 300 consecutive patients undergoing transfemoral TAVR with pre-procedural computed tomography assessment available.
The possibility to selectively cannulate each coronary, the amount of time and contrast will be evaluated in each patient before and after implantation of either balloon-(SAPIEN 3) or self-expanding (Evolut R/PRO, Acurate Neo or Portico) TAVs, thus generating an internal comparator.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices
- •Availability of preprocedural aortic root evaluation by computed tomography angiography scans
排除标准
- •TAVR in degenerated bioprostheses
- •Known ostial chronic total occlusion
- •Transcatheter valve not deployed in its anatomical position
- •Patients with hemodynamic instability during the procedure
结局指标
主要结局
Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR
时间窗: 5 minutes
Angiographic assessment of coronary ostia selective cannulation after TAVR
次要结局
- Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR(5 minutes)
研究者
Marco Barbanti
Principal Investigator
University of Catania